1. Field of the Invention
The present invention relates to a sterile container and, more particularly without limitation, to a sterile container for enclosing a non-sterile material or article therein, such as an X-ray cassette.
2. Description of the Related Art
Currently, one of the problems associated with surgery is sterilization of X-ray cassettes in the form of film holders which are used when taking X-rays with either stationary or portable units in a sterile environment. X-ray cassettes vary in size from approximately 8.times.10 inches to about 12.times.18 inches and in weight up to about 10 pounds. Unfortunately, X-ray cassettes cannot be autoclaved due to destructive damage to the X-ray film arising from the effects of heat and moisture associated therewith.
Exposing of the X-ray cassettes to ethylene oxide gas, another sterilizing agent, in addition to cost, also presents problems. Use of ethylene oxide gas has been found to generate heat, which causes the familiar difficulties to the X-ray film usually associated with heat. Also, ethylene oxide gas may create adverse chemical reactions with the X-ray film, thereby reducing its reproductive qualities.
In surgery, a non-sterile X-ray cassette must be isolated from the sterile site or field of the operation. Heretofore, many of the available containers were similar to plastic trash bags or sandwich bags. Another way sometimes used to avoid contamination of the site or field of the operation was to place the contaminated or non-sterile X-ray cassette in a sterile pillow case, such as one which had been autoclaved.
As a non-sterile person or nurse attempted to drop or move the contaminated or non-sterile cassette into the sterile bag, which was being held open by a sterile person, the edges of the sterile bag were sometimes touched by non-sterile surfaces, which could lead to subsequent contamination of other, sterile surfaces. Extra caution and effort had to be exerted by the sterile person holding the sterile bag or pillow case receiving the non-sterile article to carefully place or roll all of the contaminated surfaces and edges to the inside of the sterile bag or pillow case in order to assure that neither the sterile person nor any portion of the exterior of the bag or pillow case was contaminated by the procedure.
One solution of the problem is shown in my patent entitled, CASSETTE BAG, U.S. Pat. No. 3,843,041. In the packaging shown therein, a tubular member is releasably held in the container to protect certain exterior portions of the container from contact with a contaminated or non-sterile article or material inserted therein. After the article or material is placed inside of the container, the tubular member is removed and discarded with the non-sterile article or container safely sealed inside, leaving exterior surfaces which have retained their sterility through the procedure.
Another solution of the problem is shown in my patent entitled, STERILE CONTAINER FOR ENCLOSING A CONTAMINATED ARTICLE THEREIN, U.S. Pat. No. 3,941,245. In the packaging shown therein, an inner container is releasably supported in a sterile outer container which protects the latter from contact with a contaminated or non-sterile article or material being inserted into the inner container. The procedure of inserting the non-sterile article or material into the inner container effectively causes the inner container to be completely enveloped by the outer container. After sealing the outer container, only sterile exterior surfaces remain.
What is needed, however, is a sterile container for enclosing a contaminated or non-sterile material or article therein whereby manufacturing costs can be reduced while maintaining highly reliable and sterile handling standards, such as a singular, integrally constructed container with a tear-away throat.